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Ear Acupuncture Reducing Pain and Improving Balance (EARPIB)

Primary Purpose

Chronic Low Back Pain

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

French ear acupuncture

Sham Ultrasound

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring low back pain, French Auriculotherapy, postural control, balance, posture

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Complaints of back pain lasting more than 12 weeks
Pain referred larger than 4 according to the 11-points pain scale

Exclusion Criteria:

No other musculoskeletal injury,
Individuals diagnosed with structural damage
Individuals who performed a spine surgery
Individuals who have sensory abnormalities or dizziness.
Individuals may not be in physical therapy for reducing low back pain.
Painkillers or anti-inflammatories use 24 hours before the experimental procedure.

Sites / Locations

Laboratório de Análise do Movimento, Universidade Cruzeiro do SulRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

French ear acupuncture

Sham Ultrasound

Arm Description

Application of single session of French ear acupuncture at specific points used to reduce low back pain.

Sham ultrasound will be applied at lumbar spine.

Outcomes

Primary Outcome Measures

11-point Short Pain Scale (SPS-11)

Treatment: single session of French ear acupuncture. Placebo: 20 minute application of sham ultrasound

Secondary Outcome Measures

Center of pressure sway area

Treatment: single session of French ear acupuncture. Placebo: 20 minute application of sham ultrasound

Full Information

NCT ID

NCT01995279

First Posted

November 21, 2013

Last Updated

November 25, 2013

Sponsor

Universidade Cruzeiro do Sul

1. Study Identification

Unique Protocol Identification Number

NCT01995279

Brief Title

Ear Acupuncture Reducing Pain and Improving Balance

Acronym

EARPIB

Official Title

The Effects of a Single Session of Ear Acupuncture in Pain Sensation and Body Balance

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Unknown status

Study Start Date

November 2013 (undefined)

Primary Completion Date

March 2014 (Anticipated)

Study Completion Date

March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidade Cruzeiro do Sul

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of the present project is to examine the effects of single session of French ear acupuncture on pain sensation and on postural control in individuals with chronic low back pain. We hypothesize that: I) The application of French ear acupuncture at specific points to reduce low back pain would decrease pain intensity in patients with chronic low back pain. II) The pain reduction would be greater for those individuals with low back pain who receive application of French ear acupuncture at specific points to reduce low back pain compared with patients who receive placebo treatment. III) The application of French ear acupuncture at specific points to reduce back pain will have positive effect on the performance of the postural control system.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Low Back Pain

Keywords

low back pain, French Auriculotherapy, postural control, balance, posture

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

French ear acupuncture

Arm Type

Experimental

Arm Description

Application of single session of French ear acupuncture at specific points used to reduce low back pain.

Arm Title

Sham Ultrasound

Arm Type

Placebo Comparator

Arm Description

Sham ultrasound will be applied at lumbar spine.

Intervention Type

Device

Intervention Name(s)

French ear acupuncture

Other Intervention Name(s)

Auriculotherapy

Intervention Description

Single session (20 minutes) of French ear acupuncture at specific location used to reduce low back pain.

Intervention Type

Other

Intervention Name(s)

Sham Ultrasound

Other Intervention Name(s)

Ultrasound

Intervention Description

Ultrasound turned off.

Primary Outcome Measure Information:

Title

11-point Short Pain Scale (SPS-11)

Description

Treatment: single session of French ear acupuncture. Placebo: 20 minute application of sham ultrasound

Time Frame

20 minute

Secondary Outcome Measure Information:

Title

Center of pressure sway area

Description

Treatment: single session of French ear acupuncture. Placebo: 20 minute application of sham ultrasound

Time Frame

20 minute

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Complaints of back pain lasting more than 12 weeks Pain referred larger than 4 according to the 11-points pain scale Exclusion Criteria: No other musculoskeletal injury, Individuals diagnosed with structural damage Individuals who performed a spine surgery Individuals who have sensory abnormalities or dizziness. Individuals may not be in physical therapy for reducing low back pain. Painkillers or anti-inflammatories use 24 hours before the experimental procedure.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paulo B de Freitas, PhD

Organizational Affiliation

Associate Professor, Universidade Cruzeiro do Sul

Official's Role

Principal Investigator

Facility Information:

Facility Name

Laboratório de Análise do Movimento, Universidade Cruzeiro do Sul

City

São Paulo

State/Province

ZIP/Postal Code

01506-000

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paulo B de Freitas, PhD

Phone

+55(11)3385-3103

deFreitasPB@gmail.com

First Name & Middle Initial & Last Name & Degree

Bianca P Cunha, PT, MSc

First Name & Middle Initial & Last Name & Degree

Andrea Ushinohama, PT

12. IPD Sharing Statement

Citations:

PubMed Identifier

27556389

Citation

Ushinohama A, Cunha BP, Costa LO, Barela AM, Freitas PB. Effect of a single session of ear acupuncture on pain intensity and postural control in individuals with chronic low back pain: a randomized controlled trial. Braz J Phys Ther. 2016 Jul-Aug;20(4):328-35. doi: 10.1590/bjpt-rbf.2014.0158. Epub 2016 Jun 16.

Results Reference

derived

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Ear Acupuncture Reducing Pain and Improving Balance

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